As announced earlier this month, the longstanding Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA or Agency) and the Association of American Feed Controls Officials (AAFCO) will expire on October 1, 2024, and will not be renewed. This MOU, which has been in place for 17 years, governed FDA’s involvement in AAFCO’s animal feed ingredient definition process. While FDA has stated that the relationship between it and AAFCO is not ending, it will be evolving. Further FDA sees the expiration of the MOU as an opportunity to evaluate its pre-market animal food review programs. 

Consequently, last week, FDA released two draft guidance documents that are related to this new post-MOU period, each with a 30-day comment period that ends September 9.

Draft GFI#293 FDA Enforcement Policy for AAFCO – Defined Animal Feed Ingredients

This draft guidance describes how FDA generally does not intend to initiate action regarding food additive approval requirements for an ingredient or animal food containing the ingredient that is listed in the Official Common or Usual Names and Definitions of Feed Ingredients section in chapter six of the 2024 AAFCO Official Publication (2024 OP) if:

• The ingredient is used according to the intended use, specifications, and limitations in the definition listed in the 2024 OP, or if none, is used in accordance with good feeding practices; and
• FDA has no questions or concerns regarding the safety of the ingredient

Draft GFI#294 Animal Food Ingredient Consultation (AFIC)

This draft guidance describes FDA’s new interim Animal Food Ingredient Consultation (AFIC) process to assess ingredients for which firms may have otherwise utilized the AAFCO ingredient definition process. The AFIC consultation process also will allow for public awareness of and input on ingredients for which FDA is providing consultation and FDA intends to post inventories of pending and completed AFICs on its website. 

The guidance also explains that if, after consulting, FDA issues a “consultation complete” letter, the Agency generally does not intend to initiate action regarding the food additive approval requirements for the ingredient or animal food containing the ingredient if:

• The ingredient is used in accordance with the “consultation complete” letter; and
• There continues to be no questions or concerns regarding safety

New Webpages 

FDA has created new webpages dedicated to the AFIC process and its evaluation of the Agency’s current pre-market animal food review programs. This second webpage includes a useful Questions & Answers section regarding this interim period, such as what happens to ingredients for which FDA provided scientific and technical assistance to AAFCO under the MOU, but that are not listed in the 2024 OP.

What’s Next?

FDA has issued a Federal Register Notice soliciting comments regarding its Food Additive Petition and Generally Recognized as Safe Notification programs to determine if changes are needed to promote their efficiency. The notice seeks public input on specific questions to help the Agency determine what is working, what is not, and what changes may be needed. The comment period ends December 9, 2024. 

Given the uncertainties these changes may create, now is the time to consider the utility of the various options available regarding new animal feed ingredients. Now is also the time to consider providing comments to FDA to ensure that the Agency is aware of your questions or concerns related to these changes. FDA has stated that it does not intend to extend the 30-day comment period before it begins work on the final version of the guidances.